Kit for low profile thoracic wound seal with laterally-directed discharge

ABSTRACT

Apparatus and associated methods for a wound valve assembly provide an annular space extending radially around a central portion of a valve, which valve acts to substantially relieve pressure build up in a thoracic cavity when applied to a thoracic wound. In an illustrative example, the valve assembly may form an annular space that extends radially in all directions around a check valve. In some examples, gasses and exudates may flow substantially radially and/or parallel to the patient&#39;s local body. Various embodiments may advantageously provide open fluid communication for the gasses and exudates escaping from the wound when the valve assembly is partially covered (e.g., body armor, clothing, blankets), or when the patient may be lying down on the side of the body with the wound, for example.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is being filed as a continuation-in-part claiming thebenefit of U.S. patent application Ser. No. 12/857,522, entitled “LowProfile Thoracic Wound Seal with Laterally-Directed Discharge,” whichwas filed by Scheremet, et al. on Aug. 16, 2010; and, U.S. ProvisionalPatent Application Ser. No. 61/544,362, entitled “Hydrogel WoundCovering Membrane Having Antimicrobial and Adhesive Properties,” whichwas filed by Scheremet, et al. on Oct. 7, 2011, the entire contents ofeach of which are incorporated herein by reference.

TECHNICAL FIELD

Various embodiments relate generally to apparatus or methods for sealingthoracic wounds while relieving pressure build-up in a thoracic cavity.

BACKGROUND

In the event of a serious injury, it often falls to the first respondersto quickly stabilize a patient for transport to an appropriatelyequipped medical care facility. The first responders are often trainedto assess patients' injuries. They may often be required to determineappropriate procedures to quickly stabilize a traumatic injury, and todetermine what their limitations may be in terms of time to treat beforetransport in view of the criticality of the patient's wounds.

One type of serious injury that may be encountered as a result of, forexample, a military encounter, is a bullet or knife wound. In the eventof a gunshot or knife wound penetrating the chest or thoracic region,for example, a first responder may be equipped to apply a dressing overthe wound. Punctures that penetrate the thoracic wall, however, areserious and demand immediate medical attention. Without access to a wellequipped medical facility, there is a danger that a patient can developa life-threatening condition, such as pneumothorax, if pressure isallowed to build up in the pleural space through the wound.

SUMMARY

Apparatus and associated methods for a wound valve assembly provide anannular space extending radially around a central portion of a valve,which valve acts to substantially relieve pressure build up in athoracic cavity when applied to a thoracic wound. In an illustrativeexample, the valve assembly may form an annular space that extendsradially in all directions around a check valve. In some examples,gasses and exudates may flow substantially radially and/or parallel tothe patient's local body. Various embodiments may advantageously provideopen fluid communication for the gasses and exudates escaping from thewound when the valve assembly is partially covered (e.g., by body armor,clothing, blankets), or when the patient may be lying down on the sideof the body with the wound, for example.

Various embodiments may achieve one or more advantages. For example,some embodiments may provide an annular volume which may be maintainedto provide fluid communication to discharge fluid pressure build up inthe presence of clothing, blankets, body armor, or when laying on theside of the wound dressing assembly. Some embodiments of the valve mayprovide optical magnification to more easily inspect a check valve andto verify proper valve operation. Some embodiments may include acolor-tinted valve membrane (e.g., yellow) which may substantiallycontrast with typical exudates (e.g., including blood) to furthersimplify the inspection and verification of valve operation. Variousembodiments may include interference fit mechanisms for assembling thevalve subcomponents to a soft pliable carrier (e.g., dressing bandage)to form a wound seal system. The carrier may provide a pliable, softsubstrate for an aggressive hydrogel combined with an antimicrobial,whereby the combined assembly does not readily form channels that couldbreak a seal of the valve against the patient, thereby providing anundesirable flow communication for allowing pressure build up in thepleural cavity, for example. As a further example, some embodiments mayincorporate a hydrogel combined with an antimicrobial to releasablyadhere the valve assembly to the patient, and to permit the immediateand direct application of the valve assembly to protect against pressurebuild up from an open thoracic wound in the field, for example.

The details of various embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D depict perspective, cross-sectional, plan, and elevationviews of an exemplary valve assembly.

FIGS. 2A-2B depict exploded perspective views of the example of FIGS.1A-1D.

FIGS. 3A-3B depict cross-sectional exploded and assembled side views ofan exemplary thoracic wound seal assembly.

FIGS. 4-6 depict sets of exemplary valve membranes and correspondingmembrane platforms.

FIGS. 7A-7B depict plan views of exemplary kit for packaging anexemplary valve system.

FIG. 8 depicts an upper perspective view of an exemplary membrane.

FIG. 9 depicts a cross-sectional view of the embodiment shown in FIG. 8.

FIG. 10 depicts an exemplary side view of an embodiment illustrating themembrane being rolled.

FIGS. 11-13 depict sets of exemplary membranes.

FIGS. 14A-D depict exploded views of exemplary valve assemblies.

FIG. 15A-D depict cross sectional views of exemplary valve assemblies,such as those embodiments described with reference to FIGS. 14A-B.

FIGS. 16A-D depict plan views of exemplary thoracic wound sealassemblies.

FIGS. 17A-C depict cross sectional views of the exemplary thoracic woundseal assemblies of FIG. 16A-D.

FIGS. 18A-B depict cross sectional views of exemplary thoracic woundseal assemblies.

FIGS. 19A-B depict exploded views of exemplary valve assemblies.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

FIGS. 1A-1D depict perspective, cross-sectional, plan, and elevationviews of an exemplary valve assembly. In the depicted FIG. 1A, a lowprofile valve assembly 100 is positionable over a wound to limitpressure build-up in the thoracic cavity, for example. As will bedescribed, the valve assembly 100 is configured for assembly to a soft,pliable carrier (not shown) that forms a substantially air-tight seal tothe skin around the wound by virtue of an adhesive coating (e.g.,hydrogel) on one surface of the carrier substrate (examples of which aredescribed in further detail with reference to FIGS. 3 and 7). Forpurposes of clearly introducing embodiments of the valve assembly 100,the valve assembly 100 is shown without a carrier layer in FIGS. 1-2.

In particular examples, the valve assembly 100 may provide for radialdischarge of gasses (e.g., air) and/or exudates (e.g., blood) that mayflow out of a thoracic wound. The arrows in the FIG. 1A depict lateralflow paths for communicating fluids (e.g., blood, gasses, or otherexudates) radially away from the wound. The various flow paths permitlateral fluid flow in a plane substantially parallel to a plane tangentto the patient's body at the wound site. In some examples, substantiallylateral and radial flow paths may substantially reduce the risk that allthe flow paths will be occluded by materials (e.g., such as clothing,blankets, body armor) or when the patient is lying on the side of thebody with the valve assembly 100. In an illustrative example, a patientmay be treated with two valve assemblies 100, one on a front entrythoracic wound and one on a rear exit thoracic wound, and the patientmay need to lie down on the back during transport, for example.

The valve assembly 100 includes a bottom housing 105 and a top housing110. The housings 105, 100 each include an annular flange lying insubstantially parallel planes. Between the facing surfaces of therespective annular flanges are a number of support bosses 115. Thesupport bosses 115 are disposed in a volume between the annular flangesof the housing 105, 110 that form an annular cavity to permit lateralfluid flow discharge from the valve assembly 100 (see exemplary arrows).

In this embodiment, the top housing 110 further includes an optical gainelement, a lens 120, configured to magnify a view of an interioroperation of the valve assembly. In particular examples, the lens mayenhance an image of the valve operation, to permit an attending careprovider, to monitor operation of a unidirectional valve, for example.Operations of exemplary valves will be described in further detail, forexample, with reference to FIGS. 2-6.

FIG. 1B-1D show cross-section, top, and plan views that reveals furtherdetail of the exemplary valve assembly 100 of FIG. 1A. The bottomhousing 105 further includes support pins 125 that correspond to thesupport bosses 115. When registered in alignment and assembled, each ofthe support pins 125 provide an interference fit to engage an interiorof a corresponding one of the support bosses 115. The coupling of thesupport pins 125 to the support bosses 115 further engage a carrier (notshown in this figure). The support pins 125, being covered by thecarrier, drive a local portion of the carrier material web into thesupport bosses 115, thereby securely engaging the carrier to theassembled bottom and top housings 105, 110.

The bottom housing 105 further includes a central frame 130, whichdefines a bottom aperture 135 through which fluids pass through a valvesystem 140 and then discharge laterally through an annular cavity 145(see FIG. 1D).

In the depicted example, a bottom portion of the lens 120 includes aboss to engage and couple to a projection of the valve system. Thiscoupling may, in some embodiments, secure the valve membrane to themembrane mounting pin, as will be described in further detail withreference to FIGS. 2A-2B.

The lens 120 is depicted, as an example, with a variable thicknessprofile such that, according to the relative indices of refraction, anobserver can view an image of the interior of the valve assembly withthe benefit of a magnification factor. In some implementations, this mayadvantageously permit closer inspection of the small movements and smallquantities of materials in the valve system 140. The lens 120 portionmay be a substantially transparent plastic or glass material. In someexamples, the lens 120 may be made of a substantially different material(e.g., glass, high density polyethylene) than the remainder of the tophousing 110 (e.g., polypropylene). In some embodiments, the lens 120 maybe formed from materials arranged to provide a graded index ofrefraction (GRIN) to yield an optical gain or magnification.

FIGS. 2A-2B depict exploded perspective views of the example of FIGS.1A-1D. FIG. 2A shows an exemplary embodiment of an interior of the valvesystem 140. In particular, the central frame 130 further includes amembrane support member 150 arranged as a number of spokes formedbetween a peripheral ring and a central hub. In the depicted embodiment,a valve membrane 155 is sized to lie on the membrane support member 150within the upward extending wall of the central frame 130. The centralhub of the central frame 130 includes a mounting pin 165 to register andlocate the mount aperture 160 of the valve membrane 155.

The bottom housing 105 and the top housing 110 may extend radially froma central axis along which the mounting pin 165 is aligned. In someembodiments, a ratio of a radius to the periphery of the annular cavity145 to a radius of an outer diameter of the central frame 130 may beabout 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0,4.25, 4.5, or at least about 5.0.

Another exemplary embodiment of the valve system 140 is described, forexample, with reference at least to FIG. 4 of U.S. Pat. No. 5,160,322 toScheremet, et al., entitled “Occlusive Chest Sealing Valve,” as issuedNov. 3, 1992.

In the depicted example, the valve membrane 155 rests on the membranesupport member 150 and lies substantially in a plane. In some otherembodiments, the support member 150 may be formed as a curved (e.g.,concave, convex) surface.

FIGS. 3A-3B depict cross-sectional exploded and assembled side views ofan exemplary thoracic wound seal assembly. This embodiment depicts anexemplary valve support member having a curved surface.

FIG. 3A shows an exemplary wound seal assembly 300 that includes a base305, a carrier 330, and a valve assembly 350. When assembled, as shownin FIG. 3B, these components form an embodiment of a thoracic woundseal.

The base 305 includes a base flange 310, supports 315, and a lens 320.The supports 315 form an annular cavity 345 in the space between thebase flange 310 and an upper portion of the base 305, outside of acentral portion configured to receive the valve assembly 350.

The carrier 330 is formed of a soft, pliable material that can provide asubstrate for an adhesive layer 335 on one surface. In variousembodiments, the adhesive 335 may be selectively applied to the carrier330, for example, outside of the portion that makes contact with thevalve assembly 350. In various implementations, the adhesive 335 mayinclude a hydrogel to provide a substantially air tight seal to thepatient's skin.

In various embodiments the carrier 330 may be sufficiently soft andpliable to resist forming air channels when the patient's skin moves, orwhen initially applied to non-planar skin features. A sufficiently thicklayer of hydrogel may advantageously conform substantially to thepatient's body to allow the valve assembly 350 to maintain a substantialseal around the wound site.

In some embodiments, the hydrogel may include or be modified to includeat least one anti-microbial agent to protect the patient againstinfection. In some examples, the anti-microbial agent may include asilver-containing compound (e.g., salt of silver).

The valve assembly 350 receives a valve membrane 355 disposed on acurved membrane support 360, which has apertures through which exudatesand gasses may flow from the wound to the annular cavity 345. Themembrane support 360 rests on a valve base 365, which has a cylindricalshape. On a perimeter of the valve base 365 is disposed a ring 375 and avalve flange 390.

In the base 305, the central portion to receive the valve assembly 350includes, in this embodiment, a locating ring 370 to provide a verticalstop that locates the valve assembly 350 within the central portion. Thecentral portion further includes a recess 380.

To assemble the wound seal assembly 300, as shown in FIG. 1B, thecarrier 350 is captured between the base flange 310 and the valve flange390. The valve membrane 355 is captured along its perimeter between thelocating ring 370 and the valve base 365. The valve assembly 350 may beretained in position upon insertion when the ring 375 engages thecorresponding recess 380. The valve assembly 350 may snap into placeupon insertion such that a perimeter of the valve membrane 355 is heldin compression.

The assembled wound seal assembly 300 permits unidirectional fluid flowfrom the wound, through the valve assembly 355. Fluids may then bedischarged laterally through the annular cavity 345 in any radialdirection out of the base 305.

Operation of the perimeter-capture membrane will next be furtherdescribed with reference to the embodiments depicted in FIGS. 4-6.

FIGS. 4-6 depict sets of exemplary valve membranes and correspondingmembrane platforms. As shown in FIGS. 3A-3B, the perimeter of thesevalve membranes are captured and thus securely located. The embodimentsof FIGS. 4-6 may be implemented in a planar (flat) support member (e.g.,see membrane support member 150) or on a support member with a curvedsurface (e.g., see membrane support member 360). It is speculated by theinventors that a curved surface may be advantageous in yielding areduced tendency for the membrane to become clogged, and there may befurther advantages in sensitivity to releasing small pressures in thethoracic cavity, perhaps associated with the increased length of theaperture on a curved surface relative to a similar circumference valvein a planar format.

A valve embodiment 400 includes a membrane 405 with a single aperture410. The aperture may be formed, for example, by cutting two crossedslits in a membrane. The membrane 405 is assembled on a valve base 415so that the slits of the aperture 410 register along the correspondingmembrane supports 420.

In operation, the valve responds to fluid pressure from the wound side(below the valve seal 415) by at least a portion of the membrane alongthe aperture 410 separating from the membrane support 420, permittingfluid to flow through the aperture. In response to fluid pressure fromthe atmospheric side, the valve assembly blocks reverse flow as theedges of the aperture 410 are in pressed in intimate contact with themembrane supports 420.

Similarly, FIGS. 5 and 6 depict exemplary valve embodiments 500, 600 intriangular and elliptical shapes, with membranes 505, 605 havingapertures 510, 610, respectively. The membranes 505, 605 may beassembled on a valve base 515, 615 so that the slits of the aperture510, 610 register along the corresponding membrane support structures520, 620, respectively.

FIGS. 7A-7B depict plan views of an exemplary kit for packaging anexemplary valve system. It may be advantageous in some applications tohave a kit 700 that includes a protective package 705, a pre-moistenedanti-septic and/or anti-microbial wipe 710, and a thoracic wound seal715. In some embodiments, the thoracic wound seal 715 may include arelease liner to protect the hydrogel adhesive until ready for use. Insome implementations, the packaging 705 may serve as a release linerdirectly, which may reduce the materials and/or manufacturing cost andfurther reduce the waste stream, for example.

In some implementations, the package 705 may have a foil backing on atleast one or both sides. The package 705 may be vacuum sealed tosubstantially reduce or prevent ingress and/or egress of moisture orcontaminants. A vacuum seal may advantageously extend the service lifeof the hydrogel, for example. In some examples, the kit may include awindow on the package 705 to permit inspection of the contents. In someembodiments, the kit 700 may be rolled into a substantially cylindricalform for compact storage (e.g., in a medical bag).

FIG. 8 depicts an upper perspective view of an exemplary membrane. Thesystem 800 includes a membrane 805 and a release liner 810. The releaseliner 810 permits rapid separation when the membrane 805 is needed foruse as a wound dressing, for example.

It should be appreciated that the term “membrane” is not meant to belimiting, and may in various implementations comprise a solid,semi-solid, or liquid composition, for example a pad, a patch, or a gel.The membrane 805 may be applied over the wound in one-piece, a patch ora conventional bandage, or the membrane 805 may be spread over thewound, for example, in a liquid or fluid-gel form. The membrane 805 maybe formed into shapes of various sizes, for example, 6 inches×6 inches,12 inches×12 inches, or 4 inches×18 inches.

FIG. 9 depicts a cross-sectional view of the embodiment shown in FIG. 8.The system 900 includes a membrane 905 includes a carrier substrate 915comprised of a pliable material, for example, a hydrogel substance. Asillustrated, the carrier substrate 915 may be rectangular in shape;however other shapes may be appreciated as will be discussed inreference to FIGS. 11-13.

The carrier substrate 915 includes an impregnated antimicrobial agent920.

The antimicrobial agent 920 may be evenly dispersed throughout theinterior and/or exterior of the carrier substrate 915 or may bedispersed throughout only a portion of the carrier substrate 915, forexample, along the bottom or contact surface of the carrier substrate915.

The carrier substrate 915 includes an impregnated adhesive agent 925.The adhesive agent 925 may be evenly dispersed throughout the interiorand/or exterior of the carrier substrate 915 or may be dispersedthroughout only a portion of the carrier substrate 915, for example,along the bottom or contact surface of the carrier substrate 915. Forexample, if the adhesive agent 925 is dispersed only along a singularcontact surface (e.g., bottom surface) of the carrier substrate 915 ofthe membrane 905, the non-contact surfaces (e.g., sides, top) of thecarrier substrate 915 of the membrane 905 may include a barrier orcomposition such that would not contain the adhesive agent 925.

In another exemplary embodiment, an adhesive layer (not shown) may beformed or attached along the bottom or contact surface of the carriersubstrate 915. Such an adhesive layer may still permit the antimicrobialagent 920 to make contact with the wound or fluids dispersed from thewound. An example of the adhesive layer may include tape, for example,3M™ MEDIPORE™ TAPE, commercially available from 3M Corp. of Minnesota.

The adhesive agent 925 presents a tacky or sticky property such that themembrane 905 sticks to the supporting structure, for example, the skinof the patient, yet the adhesive agent 925 permits for easy removal ofthe membrane 905 from the supporting structure without causing asubstantial disturbance or pulling on the supporting structure. Forexample, the disturbance may include the removal of hair, damage to thewound, tearing, or removal of a scab. The adhesive agent 925 alsopermits for the membrane to be attached to wet or dirty surfaces, thusnot requiring the patient to clean the surface around the wound prior toattachment of the membrane 905.

FIG. 10 depicts an exemplary side view of an embodiment illustrating themembrane being rolled. Such an orientation of the system 1100 mayadvantageously permit convenient transport and storage of the system,such as in a medical bag or kit. FIG. 10 also illustrates themalleability of the system 1100, for example, the membrane 1105 beingadapted for attachment to various shaped surfaces. Rolling in similarmanner may be also employed for the kit 700, or various embodiments of athoracic wound seal, such as the thoracic wound seal 715, for example.

FIGS. 11-13 depict sets of exemplary shapes of the membrane describedwith reference, for example, to at least FIG. 8. The embodiments ofFIGS. 11-13 may be implemented in a planar (flat) or on a support memberwith a curved surface (e.g., see membrane support member). It isspeculated by the inventors that a curved surface may be advantageous inyielding a reduced tendency for the membrane to form to a patient's bodycontours, for example.

More particularly, FIG. 11 illustrates an exemplary embodiment 1120including a membrane 1125 having a circular shape. FIG. 12 illustratesan exemplary embodiment 1250 including a membrane 1205 having atriangular shape. FIG. 13 illustrates an exemplary embodiment 1300including a membrane 1305 having an elliptical shape.

In the example depicted in FIG. 14A, a valve assembly 1405 includes thebottom housing 105, a top housing 1410 which is adapted to be coupled tothe bottom housing 105, and the valve membrane 155 disposed between thetop housing 1410 and the bottom housing 105. The top housing 1410includes a central body portion and a plurality of radial protrusions1415 extending from a periphery of the central body portion. In variousimplementations, the radial protrusions 1415 may advantageouslysubstantially reduce or eliminate disruptions in the operation of thevalve assembly 1405. For example, the radial protrusions 1415 maymitigate occlusion of adequate fluid communication through the valveassembly 1405 between the pleural cavity and ambient atmosphere, forexample, due to blankets, clothing, bandages, bedding, and/or blood.

With reference to FIG. 1A, the radial protrusions 1415, in the depictedexample, extend from a periphery of the lens 120. In this embodiment, nostructural materials are present in the spaces between adjacent radialprotrusions 1415. In an illustrative example, a compact radiusembodiment may be particularly effective in dressing wounds in a fieldemergency situation, where the patient may be moved onto and off ofgurneys and transported by helicopter and/or ambulance.

In some embodiments of the valve assembly 1405, the radial protrusions1415 may extend radially outward starting from a greater distance fromthe center of the top housing 1410. For example, the radial protrusions1415 may extend from a periphery of the top housing 110, an example ofwhich is described at least with reference to FIG. 1A. In variousimplementations, occlusion mitigation at an increased radius from thecenter of the top housing 1410 may advantageously provide a largerannular volume 1535, an example of which is described at least withreference to FIG. 15A, through which may be more difficult toinadvertently occlude, for example, with blankets, clothing, bedding.

FIGS. 14A-14D depict exploded views of exemplary valve assemblies. FIG.14A depicts an exemplary valve assembly 1405, which includes the bottomhousing 105, a top housing 1410 which is adapted to be coupled to thebottom housing 105, and the valve membrane 155 disposed between the tophousing 1410 and the bottom housing 105. The top housing 1410 includes aframe 1415 defining a central aperture 1420. With reference to FIG. 2A,in the depicted embodiment the valve system 140 of FIG. 2A iscircumscribed within the central aperture 1420 when the assembly 1405 isassembled. In various implementations, the frame 1415 may advantageouslysubstantially reduce or eliminate disruptions in the operation of thevalve assembly 1405. For example, the frame 1415 may prevent occlusionof a valve assembly by bulk materials such as, for example, blankets,clothing, bandages, or bedding. In various implementations,circumscribing the valve system 140 within the central aperture 1420 maypromote fluid communication from the pleural cavity through the valvesystem 140 in a perpendicular direction with respect to a plane tangentto the aperture 1420. In various implementations maintaining the valvesystem 140 inside the central aperture 1420 may allow the valve system140 to be fully accessed. For example, the valve system 140 may beaccessed to be rinsed via the central aperture 1420.

FIG. 14B depicts an exemplary valve top housing assembly 1425. The valvetop housing assembly 1425 includes a top housing 1430 which may be usedas an alternative for the top housing 1410 as depicted in FIG. 14A. Withrespect to FIG. 14A, the valve top housing assembly 1425 includes thetop housing 1430 which is adapted to be coupled to the bottom housing105 in FIG. 14A. The top housing 1430 includes a frame 1435 defining acentral aperture 1420. With reference to FIG. 2A, the depicted valvesystem 140 of FIG. 2A is circumscribed within the central aperture 1420.Cross members 1440 are attached to the frame 1435 and span the centralaperture 1420. In some implementations, the cross members 1440 mayadvantageously substantially reduce or eliminate disruptions in theoperation of a valve assembly. For example, the cross members maysubstantially reduce or prevent occlusion of a valve assembly by bulkmaterials such as, for example, blankets, clothing, bandages, orbedding.

FIG. 14C depicts an exemplary valve top housing assembly 1445. The valvetop housing assembly 1445 includes a top housing 1450 which may be usedas an alternative for the top housing 1410 as depicted in FIG. 14A. Withrespect to FIG. 14A, the valve top housing assembly 1445 includes thetop housing 1450 adapted to be coupled to the bottom housing 105 of FIG.14A. The top housing 1450 includes the lens 120 and a plurality ofradial protrusions 1455 extending from a periphery of the top housing1450. With reference to FIG. 1A, the radial protrusions 1470, in thedepicted example, extend from a periphery of the top housing 110. Inthis embodiment, no structural materials are present in the spacesbetween adjacent radial protrusions 1455. In various implementations,the radial protrusions 1470 may advantageously provide a larger annularvolume 1535, which may be more difficult to inadvertently occlude, forexample, with blankets, clothing, or bedding.

FIG. 14D depicts an exemplary valve top housing assembly 1460. The valvetop housing assembly 1460 includes a top housing 1465 which may be usedas an alternative for the top housing 1410 as depicted in FIG. 14A. Withrespect to FIG. 14A, the valve top housing assembly 1460 includes thetop housing 1465 adapted to be coupled to the bottom housing 105 of FIG.14A. The top housing 1465 includes a plurality of radial protrusions1470 extending from a central portion of the top housing 1465. Withreference to FIG. 1A, the radial protrusions 1470, in the depictedexample, extend from a central portion of the top housing 110. Withreference to FIG. 1A, the radial protrusions extend to a periphery ofthe top housing 110. In this embodiment, no structural materials arepresent in the spaces between adjacent radial protrusions 1470. In someembodiments, the radial protrusions 1470 aid fluid communication throughthe top housing 1465 by allowing fluid communication through the volumedefined between the radial protrusions 1470.

With reference to FIG. 1A, the radial protrusions 1470, in the depictedexample, extend from a central portion of the top housing 110. In someembodiments, the lens 120 may be omitted, leaving an opening in itsplace. In some embodiments, omission of the lens 120 may advantageouslyaid fluid communication in the vertical direction in addition to thelateral fluid communication from the pleural cavity through the valveassembly and through the volume defined between the radial protrusions1470 to the ambient atmosphere. In various embodiments, one or moreradial protrusions 1470 may be distributed around a portion or theentirety of the top housing 1465.

With reference to FIG. 1A, in some embodiments of the valve assembly1460, the radial protrusions 1470 may extend beyond a radiuscorresponding to the periphery of the top housing 110. In variousimplementations, occlusion mitigation at an increased radius from thecenter of the top housing 1410 may advantageously provide a largerannular volume 1535, which may be more difficult to inadvertentlyocclude, for example, with blankets, clothing, or bedding.

FIGS. 15A-D depict cross sectional views of exemplary valve assemblies,such as those embodiments described with reference to FIGS. 14A-B. InFIG. 15A, a valve assembly 1505 includes a base 1510, a top housing 1520adapted to be coupled to the base 1510, and one or more supports 1515between the base 1510 and top housing 1520. The volume between the tophousing 1520 and the base 1510 defines an annular cavity 1535 and acentral cavity 1530. A valve 1525 is disposed inside the central cavity1530. The valve 1525 is in fluid communication with the ambientatmosphere by a lateral path between the central cavity 1530, theannular cavity 1535, and around the one or more supports 1515. Aplurality of radial protrusions 1540 are attached at a periphery of thetop housing 1520. The radial protrusions extend beyond a periphery ofthe base 1510. The valve assembly 1505 is depicted as coupled to acarrier layer 1545.

In FIG. 15B, an exemplary valve assembly 1545 is depicted. The valveassembly 1545 includes a plurality of radial protrusions 1550 attachedto a periphery of the top housing 1520. In some examples, the radialprotrusions may be integrally formed and extend from the central tophousing 1520. In some implementations, the radial protrusions may coupleto the housing in a temporary or permanent manner. By way of example andnot limitation, the radial protrusions may clip on to the top housing,snap-in (e.g., tongue-in groove) fit, or threadingly engage the tophousing 1520.

The radial protrusions 1550 extend downward. In some embodiments, thedownward extension may substantially reduce or prevent the chance ofocclusion of fluid flow through the valve assembly by excludingencroachment, for example, of bulk materials (e.g., fabric, clothing)into the annular cavity 1535 of the valve assembly.

In FIG. 15C, a valve assembly 1555 is depicted. The valve assemblyincludes a plurality of radial protrusions 1560 attached to the tophousing 1520. In the depicted embodiment, the lateral dimension of thecentral body portion of the top housing 1520 is reduced such that theprotrusions 1560 do not extend substantially beyond the lateraldimension of the base 1510. In the depicted embodiment, the annularcavity 1535 is formed in part by the volume defined between the base1510 and the top housing 1520 and in part by the volume defined betweenthe base 1510 and the radial protrusions 1560.

In FIG. 15D, an exemplary valve assembly 1565 includes a plurality ofprotrusions 1570 attached to or extending from the top housing 1520. Inthe depicted embodiment, the annular cavity 1535 is defined by the base1510 and the radial protrusions 1570. In some embodiments, the radialprotrusions 1570 defining the annular cavity 1535 may allow forincreased fluid communication in a direction perpendicular to the radialprotrusions 1570, for example, from the pleural cavity, through thevalve 1525, and with reference to FIG. 14A, through the volume definedby the spacing between the radial protrusions 1415.

FIGS. 16A-D depict plan views of exemplary thoracic wound sealassemblies. In FIG. 16A, wound seal assembly 1605 includes a carrierlayer 1625, a valve body 1610 coupled to the carrier layer 1625, and aplurality of radial protrusions 1620 coupled to the carrier layer 1625.The valve body 1610 includes a flange 1615. The plurality of radialprotrusions 1620 extend radially and are operatively adjacent to aperiphery of the flange 1615. Fluid communication through the wound sealassembly 1605 is radial from the center of the valve body 1610 throughthe periphery of the valve body 1610, through the flange 1615, andthrough the space defined between the radial protrusions 1620. In someembodiments, the radial protrusions 1620 may substantially reduce orprevent occlusion of lateral fluid communication at the periphery of theflange 1615.

In FIG. 16B, an exemplary wound seal assembly 1630 includes the carrierlayer 1625, the valve body 1610 coupled to the carrier layer 1625, and aplurality of bumps or nodules 1635 operatively adjacent to the valvebody 1610 and coupled to the carrier layer 1625. The bumps or nodules1635 define pathways that allow for lateral fluid communication betweenthe periphery of the valve body 1610 and the ambient atmosphere. In thedepicted embodiment, the bumps or nodules 1635 are rectangular. In someembodiments, the bumps or nodules 1635 may be square, triangular,circular, or combination of shapes suitable for maintaining fluidcommunication via lateral pathways between the nodules 1635. In someembodiments, the bumps or nodules 1635 may be attached to the carrierlayer 1625 with an adhesive-backing, wherein the nodules 1635 may beslipped into position around the valve body 1610 and adhered to a topsurface of the carrier layer 1625. In other embodiments, the bumps ornodules 1635 and carrier layer 1625 may form a unitary body.

In FIG. 16B, the bumps or nodules 1635 define pathways that allow forlateral fluid communication between the periphery of the valve body 1610and the ambient atmosphere. In some examples, the bumps or nodules mayallow the carrier layer 1625 and the wound seal assembly to be rolled orflexed in the area of the carrier layer 1625 containing the bumps ornodules 1635, for example, to more easily conform to the contours of apatient's body.

In FIG. 16C, an exemplary wound seal assembly 1640 includes the carrierlayer 1625, the valve body 1610 coupled to the carrier layer 1625, and aplurality of structures 1645 operatively adjacent to the valve body 1610and coupled to the carrier layer 1625. The structures are spaced fromone another to form one or more pathways extending outward from theperiphery of the valve body 1610. Fluid communication through the woundseal assembly may include radially and/or tangentially-directedcomponents from the center of the valve body 1610, through the peripheryof the valve body 1610, and through the pathways defined between thestructures 1645.

In some embodiments, the structures 1645 and base layer 1650 may beattached to the carrier layer 1625 during manufacture. In someembodiments, the structures 1645 and base layer 1650 may be attachedwith an adhesive. In other embodiments, the structures 1645 and carrierlayer 1625 may form a unitary piece of material, and base layer 1650 maybe omitted. In other embodiments, the structures 1645 may be attached tothe carrier layer 1625 during use. For example, one or more structures1645 on a base layer 150 with a peel away adhesive backing could beincluded with a wound seal assembly as part of a kit. With reference toat least FIGS. 16A and 16B, the described methods of attachment may alsoapply to the radial protrusions 1615 and bumps or nodules 1635.

In FIG. 16D, an exemplary wound seal assembly 1665 includes the valvebody 1610, with an open cell foam or mesh ring 1670 operatively adjacentto the valve body 1610. The valve body 1610 and open cell foam or meshring 1670 are coupled to a carrier layer 1625. In some embodiments, theopen cell foam or mesh ring 1670 may allow for lateral fluidcommunication from the periphery of the valve body 1610 through thematerial comprising the open cell foam or mesh ring 1670. In someembodiments, the open cell foam or mesh ring 1670 may reduce or preventocclusion of the valve body 1610 by bulk materials during use. In someembodiments, the open cell foam or mesh ring 1670 may function as aparticulate filter. By way of example but not limitation, the open foamcell or mesh ring 1670 may include a thin screen covering lateralapertures in the valve body 1610.

FIG. 17A-C depict cross sectional views of exemplary thoracic wound sealassemblies, examples of which are described with reference to FIG. 16.

In FIG. 17A, an exemplary wound seal assembly 1705 includes a valvehousing 1710 defining an annular cavity 1725 and a central cavity 1720.A valve 1715 is disposed inside the central cavity 1720. A plurality ofstructures 1730 are operatively adjacent the valve housing 1710. Thestructures 1730 and the valve housing 1710 are coupled to a carrierlayer 1755. The valve 1715 is in fluid communication with the ambientatmosphere by a lateral path between the central cavity 1720, theannular cavity 1725, and pathways defined between the plurality ofstructures 1730. With reference to FIGS. 16A-D, the pathways between thestructures 1730 correspond to pathways defined by the spacings betweenradial protrusions 1620, by the spacings between bumps or nodules 1635,by the spacings between the structures 1645, or through the materialcomprising the foam or mesh ring 1670.

In FIG. 17B, an exemplary wound seal assembly 1735 includes a pluralityof structures 1740 spaced at a distance from the valve housing 1710. Thestructures 1740 and the valve housing 1710 are coupled to a carrierlayer 1755. In some examples, the spacing between the structures 1740and the valve housing 1710 allows the carrier 1755 layer to flex toconform to a user's body. With reference to FIGS. 16A-D, the spacingbetween the structures 1740 and the valve housing 1710 may correspond,in some embodiments, to spacing defined between the valve body 1610 andthe radial protrusions 1620, the bumps or nodules 1635, the structures1645, or the foam or the mesh ring 1670.

In FIG. 17C, a valve assembly 1745 includes a plurality of structures1750 operatively adjacent the valve housing 1710. The structures 1750and the valve housing 1710 are coupled to a carrier layer 1755. Thespacing between structures 1750 define pathways which allow for lateralair flow away from the valve housing 1710. With reference to FIGS.16A-D, the pathways between the structures 1750 correspond to pathwaysdefined by the spacings between radial protrusions 1620, by the spacingsbetween the bumps or nodules 1635, by the spacings between thestructures 1645, or through the material that forms the foam or meshring 1670. In the valve assembly 1745, the valve housing 1710 has acentral cavity 1720 and a minimal or no overhanging feature. Forexample, with reference to FIGS. 16A-D, the valve housing 1710corresponds to the valve housing 1610 with no flange 1615. In someexamples, removing or reducing the flange that forms the annular cavityfrom the valve housing allows for a reduced-diameter, more compact valvehousing 1710. In some examples, a smaller valve housing 1710 may allow awound seal assembly to be more easily rolled for compact storage (e.g.,in a medical pouch). In various examples, a smaller valve housing mayallow a wound seal assembly to more readily conform to the contours ormotion of a user's body.

FIG. 18A-B depicts cross sectional views of exemplary thoracic woundseal assemblies. In FIG. 18A, an exemplary wound seal assembly 1805includes a bottom housing 1825 coupled to one or more supports 1860,coupled to a top housing 1810. The volume between the top housing 1810and bottom housing 1825 defining a central cavity 1820. A valve 1815 isdisposed inside the central cavity 1820. The valve housing is coupled toa carrier layer 1855. The valve 1815 is in fluid communication with theambient atmosphere by one or more lateral pathways between supports1860. In some embodiments, the top housing may reduce or prevent thechances for occlusion of fluid communication through the wound assemblyduring use, such as, for example, occlusion or interference with thevalve 1815 by bulk materials.

In FIG. 18B, wound seal assembly 1805 includes a bottom housing 1825coupled to one or more supports 1860, coupled to a top housing 1810. Thevolume between the top housing 1810 and bottom housing 1825 defining acentral cavity 1820. A valve 1815 is disposed inside the central cavity1820. The valve housing is coupled to a carrier layer 1855. The valve1815 is in fluid communication with the ambient atmosphere by one ormore lateral pathways between supports 1860. An open cell foam or mesh1870 is disposed at a periphery of the central cavity 1820. In someembodiments, the open cell foam or mesh 1870 may function as aparticulate filter. In some embodiments, for example, the open cell foamor mesh 1870 may comprise a thin screen.

FIGS. 19A-B depict exploded views of exemplary valve assemblies. In FIG.19A, an exemplary valve assembly 1900 includes a base 1905, a valve 1910coupled to the base 1905, and a valve membrane 1915 disposed on thevalve 1910. A plurality of structures 1920 are disposed around theperiphery of the valve 1910 and coupled to the base 1905. The structures1920 define pathways for fluid communication between a periphery of thevalve 1920 and the ambient atmosphere. In some embodiments, thestructures 1920 prevent or greatly reduce the possibility of theocclusion of fluid communication through the valve due to bulk materialswhich can block the valve.

In FIG. 19B, an exemplary valve assembly 1930 includes the base 1905,the valve 1910 coupled to the base 1905, and the valve membrane 1915disposed on the valve 1910. The plurality of structures 1920 aredisposed around the periphery of the valve 1910 and coupled to the base1905. Protective members 1935 are disposed to overlie the valve 1910. Insome embodiments, the protective members 1935 prevent or greatly reducethe possibility of the occlusion of fluid communication through thevalve due to bulk materials which can block the valve.

Although various embodiments have been described with reference to thefigures, other embodiments are possible. For example, portions of thehousings 105, 110 may be coated with active materials, such asanti-microbials (e.g., silver). Some portions of the valve, such as thevalve membrane and/or the interior surfaces of the valve housing may bepartially or completed coated with a lubricious material to promote theflow of exudates, which may reduce the risk of occlusion of valvepathways.

Some embodiments of the valve assembly may omit the lens. In someapplications, this may permit use of stronger, thinner plasticmaterials. In some examples, omission of the lens may permit a lowerprofile, which may be more comfortable when the patient lies down on theside with the valve assembly. Lower profiles may also permit the valvecavity to be enlarged to accommodate larger wounds.

In some implementations, it may be advantageous to provide a bandage orwound seal without the valve assembly. For example a wound seal may beformed of a carrier, a hydrogel, and an anti-microbial agent included inthe hydrogel. The hydrogel may be stored between the carrier and arelease liner that can be rapidly removed when needed for use as a wounddressing.

In various embodiments, the membrane may have visual indicia to make iteasier to detect operation of the membrane that may be associated withpressure release from the thoracic cavity. In some examples, themembrane itself may be tinted yellow to distinguish it from the othersubstances that may be present in the valve (e.g., blood). The membranemay have dots, stripes, or other variations in color or markings to helpthe observer readily distinguish and identify the membrane through thelens, and to verify correct operation of the valve membrane, forexample.

In some embodiments, such as those described with reference to FIGS.3A-3B, means for attaching the carrier 300 to the base 305 include acompressive interference between the valve flange 390 and the baseflange 310. In another embodiment, the valve flange 390 may beconfigured with a number of plastic posts that penetrate the carrier330; in assembly, the posts may be transformed (e.g., by ultrasonicwelding or heat staking process) into a shape or form (e.g., rivet head)that retains the carrier 330.

A number of implementations have been described. Nevertheless, it willbe understood that various modification may be made. For example,advantageous results may be achieved if the steps of the disclosedtechniques were performed in a different sequence, or if components ofthe disclosed systems were combined in a different manner, or if thecomponents were supplemented with other components. Accordingly, otherimplementations are contemplated within the scope of the followingclaims.

What is claimed is:
 1. A thoracic valve seal kit, comprising: a thoracic valve seal system, comprising: a carrier layer formed of a substantially pliable sheet material; an adhesive material on one surface of the carrier layer; a valve that permits fluid to flow through the valve in substantially only one direction; a housing that couples to the carrier layer and that, when sealed around a wound by the adhesive material on the carrier layer, supports the valve in an orientation relative to the patient's body to permit fluids to flow substantially only from the wound to a region outside of the body, the housing comprising: a bottom housing that includes a sealing cavity to provide fluid communication from the wound to the valve when sealed around the wound; and, a top housing that couples to the bottom housing, wherein the top housing includes a flange that extends radially around a periphery of the valve to form an annular space between the top housing and the bottom housing; a pre-moistened wipe; and, a protective package enclosing the thoracic valve seal system and the pre-moistened wipe.
 2. The thoracic valve seal kit of claim 1, wherein the adhesive material comprises a hydrogel.
 3. The thoracic valve seal kit of claim 2, wherein the adhesive material further comprises an ingredient with an effective amount of an anti-microbial agent.
 4. The thoracic valve seal kit of claim 1, wherein the valve comprises a flexible membrane.
 5. The thoracic valve seal kit of claim 1, further providing an annular coupling from the housing to a periphery of the flexible membrane.
 6. The thoracic valve seal kit of claim 1, wherein the top housing and the bottom housing include a plurality of interference fit features to mate to each other.
 7. The thoracic valve seal kit of claim 1, wherein the top housing and the bottom housing include a plurality of interference fit features extending between the top and the bottom housing to mate to each other and to couple the housing to the carrier layer.
 8. The thoracic valve seal kit of claim 1, wherein the provided housing forms an aperture that provides fluid communication from an exhaust side of the valve to the annular space between the top housing and the bottom housing.
 9. The thoracic valve seal kit of claim 8, further comprising a cavity to provide fluid communication through the apertures in a plane substantially parallel to a plane tangent to the wound.
 10. The thoracic valve seal kit of claim 1, wherein the top housing further comprises a lens to magnify an image of the valve.
 11. A method of treating a thoracic puncture wound, the method comprising: providing a carrier layer formed of a substantially pliable sheet material; providing an adhesive material on one surface of the carrier layer; providing a valve that permits fluid to flow through the valve in substantially only one direction; providing a housing that couples to the carrier layer and that, when sealed around a wound by the adhesive on the carrier layer, supports the valve in an orientation relative to the patient's body to permit fluids to flow substantially only from the wound to a region outside of the body, the housing comprising: a bottom housing that includes a sealing cavity to provide fluid communication from the wound to the valve when sealed around the wound; and, a top housing that couples to the bottom housing, wherein the top housing includes a flange that extends radially around a periphery of the valve to form an annular space between the top housing and the bottom housing; and, providing a protective package enclosing: a pre-moistened wipe; and the carrier layer, the adhesive material, the valve, and the housing.
 12. The method of claim 11, wherein the adhesive material comprises a hydrogel.
 13. The method of claim 12, wherein the adhesive material further comprises an ingredient with an effective amount of an anti-microbial agent.
 14. The method of claim 11, wherein the valve comprises a flexible membrane.
 15. The method of claim 11, further providing an annular coupling from the housing to a periphery of the flexible membrane.
 16. The method of claim 11, further providing the top housing and the bottom housing include a plurality of interference fit features to mate to each other.
 17. The method of claim 11, wherein the top housing and the bottom housing include a plurality of interference fit features extending between the top and the bottom housing to mate to each other and to couple the housing to the carrier layer.
 18. The method of claim 11, wherein the provided housing forms a plurality of apertures that provide fluid communication from an exhaust side of the valve to the annular space between the top housing and the bottom housing.
 19. The method of claim 11, further comprising providing a lens in the top housing to magnify an image of the valve.
 20. The method of claim 11, further comprising providing a yellow tint on the membrane. 